NCT01448811

Brief Summary

To compare the difference of sedation monitoring for bronchoscopic examination monitoring by auditory evoked potentials (AEP) or Ramsay Sedation Scale (RSS) in mechanical ventilated patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2011

Completed
Last Updated

October 12, 2011

Status Verified

October 1, 2011

Enrollment Period

1 year

First QC Date

October 6, 2011

Last Update Submit

October 7, 2011

Conditions

Sedation Method

Outcome Measures

Primary Outcomes (1)

  • Change of mean arterial pressure, heart rate and AAI

    During bronchoscopy, we recorded AAI number, blood pressure and heart rate every 5 minutes, totally up to 40 minutes.

    40 minutes

Secondary Outcomes (1)

  • mean propofol dose use during examination, times of propofol dose adjustment

    40 minutes

Study Arms (2)

AEP monitoring

EXPERIMENTAL
Device: AEP monitor

RSS monitoring

ACTIVE COMPARATOR
Procedure: Ramsay Sedation Scale

Interventions

AEP monitorDEVICE

In AEP monitoring group, nurses adjusted propofol dose according to AAI values. If AAI\>40, titrate up propofol dosage, AAI\<25, titrated down propofol dosage.

AEP monitoring
Ramsay Sedation ScalePROCEDURE

During bronchoscopy, nurses adjusted propofol dose according to Ramsay Sedation Scale.

RSS monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mechanically ventilated patients with aged 18 or over and they needed bronchoscopic examination in the ICU were eligible for this study.

You may not qualify if:

  • patients with pacemaker, neuromuscular blockades, propofol allergy or hearing impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan, 813, Taiwan

Location

Related Publications (1)

  • Hsu CW, Sun SF, Chu KA, Lee DL, Wong KF. Monitoring sedation for bronchoscopy in mechanically ventilated patients by using the Ramsay sedation scale versus auditory-evoked potentials. BMC Pulm Med. 2014 Feb 6;14:15. doi: 10.1186/1471-2466-14-15.

    PMID: 24499010DERIVED

Study Officials

  • Chien-Wei Hsu, MD

    Kaohsiung Veterans General Hospital.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisted Professor

Study Record Dates

First Submitted

October 6, 2011

First Posted

October 7, 2011

Study Start

March 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

October 12, 2011

Record last verified: 2011-10

Locations

TW(1)